Summary

Eligibility
for females ages 50-75 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion

Description

Summary

Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.

Official Title

Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 3, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial

Keywords

Healthy Atenolol Atenolol 50 MG

Eligibility

You can join if…

Open to females ages 50-75

  • Able and willing to provide informed consent
  • Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
  • Aged 50-75 years

You CAN'T join if...

  • Clinical diagnosis of diabetes mellitus requiring insulin
  • Clinically significant abnormality in any of the additional screening laboratory studies
  • A1c- ≥8
  • Calcium - > upper limit lab value per site
  • AST- 2x upper normal limit
  • FSH- < 16IU/L
  • eGFR- < 45 mL/min/1.73m2 based on creatinine
  • CBC- Per PI interpretation of each patient
  • Presence of (documented clinical diagnosis of any of the following):
  • Significant liver or renal disease
  • Malignancy (including myeloma or clinical diagnosis of MGUS)
  • Malabsorption (as defined by clinical diagnosis)
  • Hypoparathyroidism (as defined by clinical diagnosis)
  • Hyperparathyroidism (as defined by clinical diagnosis)
  • Acromegaly
  • Cushing syndrome
  • Hypopituitarism
  • Severe chronic obstructive pulmonary disease
  • Pheochromocytoma
  • History of cardiac failure
  • Ejection Fraction <35%
  • PR interval > 200 msec on screening ECG or known heart block
  • History of bronchospastic disease
  • Gastric Bypass
  • Parkinson's
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Connective Tissue disease
  • Undergoing treatment with any medications that affect bone turnover, including the following:
  • adrenocorticosteroids (oral for > 3 months within the past year or sustained inhaled corticosteroid use)
  • anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the previous year) pharmacological doses of: thyroid hormone (causing decline of thyroid stimulating hormone below normal, i.e. < 0.3 miU/L) bisphosphonates (within the past 3 yrs) denosumab, romosozumab, estrogen therapy or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (within the past year)
  • Current use of calcium channel blockers
  • Current use of digitalis glycosides
  • Current or within the past 3 months use of thiazide diuretics
  • Current or within the past 3 months use of beta blockers
  • Clinical history of osteoporotic fracture (vertebral, hip, distal forearm, humerus, or pelvis), or any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
  • Evidence of moderate/severe vertebral deformity based on DXA vertebral fracture assessment at screening
  • Spine or femur neck T-score ≤ -2.5, or 1/3 radius T-score ≤ -3, as they may be candidates for standard osteoporosis drugs
  • Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency
  • Resting systolic blood pressure < 120 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Sundeep Khosla, M.D.
ID
NCT04905277
Phase
Phase 3
Study Type
Interventional
Last Updated